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Choroidal Change on OCTA in Eyes With High Myopia

Primary Purpose

Myopia, Progressive, Choroid Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Optic coherence tomography angiography (OCTA)
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myopia, Progressive focused on measuring OCTA, Myopia, Choroid

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Spherical equivalent measurement can be included in above 4 groups
  2. Willing to be followed up in the future 10 years

Exclusion Criteria:

  1. Deny to sign the patient consent, or deny to be followed
  2. Evidence of cardiac, or diabetic, or CNS disease.
  3. Clinically diagnosed with retinal or choroidal disease
  4. Glucoma
  5. Cataract or corneal disease that influence the quality of fundus OCTA image

Sites / Locations

  • First Affiliated Hospital of Nanjing Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1/Control

Group 1/Myopia

Group 3/High

Group 4/Super High

Arm Description

Spherical equivalent: -2.00～+2.00 D

Spherical equivalent: -3.00～-6.00 D

Spherical equivalent: -6.00～-10.00 D

Spherical equivalent: <-10.00

Outcomes

Primary Outcome Measures

Parapapillary choroidal microvasculature void (MvV) area
area of parapapillary choroidal microvasculature void on OCTA images
Parapapillary choroidal microvasculature void (MvV) area
area of parapapillary choroidal microvasculature void on OCTA images
Parapapillary choroidal microvasculature void (MvV) area
area of parapapillary choroidal microvasculature void on OCTA images
Parapapillary choroidal microvasculature void (MvV) area
area of parapapillary choroidal microvasculature void on OCTA images
Parapapillary choroidal microvasculature void (MvV) area
area of parapapillary choroidal microvasculature void on OCTA images

Secondary Outcome Measures

MvV number
number of choroidal MvV with certain size
Correlation coefficient between choroidal MvV and refractive power
Correlation coefficient between choroidal MvV and refractive power
Correlation coefficient between choroidal MvV and PPA area
Correlation coefficient between choroidal MvV and parapapillary atrophy beta area
Correlation coefficient between choroidal MvV and choroid thickness
Correlation coefficient between choroidal MvV and choroid thickness
Correlation coefficient between choroidal MvV and RNFL thickness
Correlation coefficient between choroidal MvV and RNFL thickness
Correlation coefficient between choroidal MvV and Axial length
Correlation coefficient between choroidal MvV and Axial length
Correlation coefficient between choroidal MvV and retinal parapapillary perfusion
Correlation coefficient between choroidal MvV and retinal parapapillary perfusion on OCTA images.
Correlation coefficient between choroidal MvV and Macular perfusion
Correlation coefficient between choroidal MvV and Macular perfusion on OCTA images, Retinal parapapillary perfusion with OCTA.

Full Information

First Posted
January 31, 2020
Last Updated
February 2, 2020
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04255524
Brief Title
Choroidal Change on OCTA in Eyes With High Myopia
Official Title
OCTA to Quantify the Parapapillary Choroidal Microvascular Changes in High Myopia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2030 (Anticipated)
Study Completion Date
December 31, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Myopia is a global healthy concern, especially the high myopia and pathological myopia among Asian populations. However, its mechanism still remains largely unclear. Recent findings suggested choroidal changes might be related to the development of myopia. This study is to useOCT angiography (OCT-A) to investigate parapapillary choroidal microvasculature change in myopic eyes, and try to find the cause-and-effect relationship between choroidal change and the development of myopia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Progressive, Choroid Disease
Keywords
OCTA, Myopia, Choroid

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1/Control
Arm Type
Experimental
Arm Description
Spherical equivalent: -2.00～+2.00 D
Arm Title
Group 1/Myopia
Arm Type
Experimental
Arm Description
Spherical equivalent: -3.00～-6.00 D
Arm Title
Group 3/High
Arm Type
Experimental
Arm Description
Spherical equivalent: -6.00～-10.00 D
Arm Title
Group 4/Super High
Arm Type
Experimental
Arm Description
Spherical equivalent: <-10.00
Intervention Type
Device
Intervention Name(s)
Optic coherence tomography angiography (OCTA)
Intervention Description
Using non-invasive, repeatable, mature device OCTA to obtain choroidal angio-map
Primary Outcome Measure Information:
Title
Parapapillary choroidal microvasculature void (MvV) area
Description
area of parapapillary choroidal microvasculature void on OCTA images
Time Frame
changes of MvV area from at 10 years
Title
Parapapillary choroidal microvasculature void (MvV) area
Description
area of parapapillary choroidal microvasculature void on OCTA images
Time Frame
difference of MvV area in each group at baseline
Title
Parapapillary choroidal microvasculature void (MvV) area
Description
area of parapapillary choroidal microvasculature void on OCTA images
Time Frame
changes of MvV area at 1 years
Title
Parapapillary choroidal microvasculature void (MvV) area
Description
area of parapapillary choroidal microvasculature void on OCTA images
Time Frame
changes of MvV area at 3 years
Title
Parapapillary choroidal microvasculature void (MvV) area
Description
area of parapapillary choroidal microvasculature void on OCTA images
Time Frame
changes of MvV area at 5 years
Secondary Outcome Measure Information:
Title
MvV number
Description
number of choroidal MvV with certain size
Time Frame
baseline
Title
Correlation coefficient between choroidal MvV and refractive power
Description
Correlation coefficient between choroidal MvV and refractive power
Time Frame
baseline
Title
Correlation coefficient between choroidal MvV and PPA area
Description
Correlation coefficient between choroidal MvV and parapapillary atrophy beta area
Time Frame
baseline
Title
Correlation coefficient between choroidal MvV and choroid thickness
Description
Correlation coefficient between choroidal MvV and choroid thickness
Time Frame
baseline
Title
Correlation coefficient between choroidal MvV and RNFL thickness
Description
Correlation coefficient between choroidal MvV and RNFL thickness
Time Frame
baseline
Title
Correlation coefficient between choroidal MvV and Axial length
Description
Correlation coefficient between choroidal MvV and Axial length
Time Frame
baseline
Title
Correlation coefficient between choroidal MvV and retinal parapapillary perfusion
Description
Correlation coefficient between choroidal MvV and retinal parapapillary perfusion on OCTA images.
Time Frame
baseline
Title
Correlation coefficient between choroidal MvV and Macular perfusion
Description
Correlation coefficient between choroidal MvV and Macular perfusion on OCTA images, Retinal parapapillary perfusion with OCTA.
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Spherical equivalent measurement can be included in above 4 groups Willing to be followed up in the future 10 years Exclusion Criteria: Deny to sign the patient consent, or deny to be followed Evidence of cardiac, or diabetic, or CNS disease. Clinically diagnosed with retinal or choroidal disease Glucoma Cataract or corneal disease that influence the quality of fundus OCTA image
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zizong Hu, PhD, MD
Phone
+8615195960100
Email
huzizhong@njum.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Qinghuai Liu, PhD, MD
Phone
+8615195960100
Email
liuqh@njmu.edu.cn
Facility Information:
Facility Name
First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
After completion of the prospective observational study, we would like to share data for reasonable request from other researchers.

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Choroidal Change on OCTA in Eyes With High Myopia

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